Surgical Instrument

ABSTRACT

A surgical apparatus for use in endoscopic surgery having a user interface operatively coupled to an articulating tool assembly via an elongate tubular member. Movement at the articulating tool directly corresponds to movement at the user interface thereby providing intuitive operation of the surgical apparatus. The apparatus is configured such that the range of motion of the articulating tool assembly emulates the range of motion of the human wrist.

RELATED APPLICATION

This application is a continuation of U.S. patent Ser. No. 13/580,353filed on Aug. 21, 2012 which is a national stage entry of PCTApplication No. PCT/US11/27061 filed on Mar. 3, 2011, which claims thebenefit of U.S. Provisional Application No. 61/309,999 filed on Mar. 3,2010, which is hereby incorporated by reference in its entirety.

BACKGROUND

Minimally invasive surgery (MIS), such as laparoscopic surgery andthoracoscopic surgery are specialized types of surgery in the broaderfield of endoscopy. Laparoscopic surgery includes operations within theabdominal and pelvic cavities; thoracoscopic surgery includes operationswithin the thoracic cavity. Various tools and instruments are utilizedduring these procedures.

Such tools for MIS include robotic assisted instruments and variousforms of hand-operated instruments. Unfortunately, robotic assistedinstruments require extensive training, are expensive and bulky.Additionally, some hand-operated instruments are counter-intuitive, i.e.movement in the tool end is opposite from movement at the user interfaceor actuation end. For instance, when the operator moves the userinterface right, the tool end moves left. Like the counter-intuitiveinstruments, intuitive hand-operated instruments have limited mobilityand flexibility. Movements are more discrete, such as left, right, up,down; however, these devices do not provide transitional movementthrough all angular ranges. Thus, in order to obtain furtherarticulation of the tool end, the user must physically repositionhim/herself and/or the instrument.

SUMMARY

The instrument described herein provides an intuitive hand-operatedinstrument that provides tactile feedback capable of intricate movementshaving range of motion comparable to that of a human wrist. Further, theinstrument described herein is a low cost, reliable, portable instrumentthat is safe for use in surgery, durable for repeated use, adaptable tothe physical limitations of various procedures, and is easy to learn anduse.

In one embodiment, the current invention is a surgical instrumentincluding a user interface operatively coupled to an articulating toolassembly through an elongate tubular member having a distal end and aproximal end. The user interface is coupled to the proximal end of theelongate tubular member and the articulating tool assembly coupled tothe distal end of the elongate tubular member. At least one cablingmember extends through the elongate tubular member connecting the userinterface and the articulating tool assembly such that movement of theuser interface causes corresponding movement in the same direction ofthe user interface at the articulating tool assembly.

The objects, features and advantages of the instrument will be readilyapparent to those skilled in the art upon a reading of the descriptionof preferred embodiments which follows when taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the instrument.

FIG. 2 is an isometric view of the instrument.

FIG. 3 is an exploded view of the instrument.

FIG. 4 shows a top view of the support assembly.

FIG. 5a shows a side cross sectional view of the articulating toolassembly and elongate tubular member of the instrument.

FIG. 5b is a side cross sectional view of the user interface of theinstrument.

FIG. 5c is a side cross sectional view of another embodiment of the userinterface.

FIG. 6 shows one embodiment of the articulating tool assembly.

FIG. 7 an exploded isometric view of the front of the tip assembly.

FIG. 8 is an exploded isometric view of the back of the tip assembly.

FIG. 9 is a cross sectional view of the back of base member of the tipassembly.

FIG. 10 is an isometric view of the dual hinge member of thearticulating tool assembly.

FIG. 11 is an isometric view of the elongate guide member of thearticulating tool assembly.

FIG. 12 is a cross sectional view of the elongate guide member.

FIG. 13 is an isometric view of the guide member.

FIG. 14 is a cross sectional view of the guide member.

FIG. 15 is an isometric view of the ball of the ball and socketassembly.

FIG. 16 is an isometric view of the back of the socket members of theball and socket assembly.

DETAILED DESCRIPTION

FIGS. 1 and 2 depict a side view and isometric view, respectively, ofinstrument 100. Instrument 100 may be manufactured from any suitablesurgically safe materials such as but not limited to stainless steel,aluminum, titanium, plastics and composites. Instrument 100 includeselongate tubular member 1 having a distal end 2 and a proximal end 3.Instrument 100 also includes user interface 4 coupled to proximal end 3,and an articulating tool assembly 5 coupled to distal end 2. Userinterface 4 is operatively connected to articulating tool assembly 5 byat least one cabling member 6 extending through elongate tubular member1. User interface 4 controls or manipulates articulating tool assembly 5such that movement at user interface 4 is translated to articulatingtool assembly 5. The range of motion of articulating tool assembly 5 iscomparable to that of the human wrist.

Instrument 100 provides one-handed operation and direct tactilesensations transmitted to the user during use. Since user input ormovement of user interface 4 provides identical mirror like movement ofarticulating tool assembly 5, instrument 100 is intuitive and easy tolearn and operate. Instrument 100 will normally be used in a variety offields where the distal end 2 and articulating tool assembly 5 will beseparated from the user interface 4 by a barrier. Typically,articulating tool assembly 5 will be disposed within a cavity, forexample but not limited to, an anatomical cavity (not depicted), withuser interface 4 disposed external to the cavity. In a preferredembodiment, instrument 100 is used for performing open surgicalprocedures and endoscopic procedures such as laparoscopic andthorascopic surgeries on human subjects and veterinary subjects.

FIG. 3 is an exploded view of one embodiment of instrument 100. Turningfirst to user interface 4 as depicted in FIGS. 1-3, user interface 4includes handle assembly 7 operatively coupled to ball and socketassembly 11, and a support assembly 23. Support assembly 23 includesfirst and second end walls 27 a, 27 b, and support rails 28 extendingtherebetween. First and second end walls 27 a, 27 b are made of materialsuitable for use in surgery. However, sample instrument 100 suitable forteaching and demonstration purposes, may use a lightweight, transparentmaterial, such as a transparent thermoplastic, for example poly(methylmethacrylate) in place of the standard surgical end walls 27. End walls27 have an approximate height and width ranging from about 30 mm toabout 60 mm with a preferred height and width of about 50.04 mm (1.97in) with a thickness of ranging from about 8 mm to about 25.4 mm with apreferred thickness of about 20.07 mm (0.79 in). Support rails 28 arereceived in cavities 43 having a diameter 5.08 mm (0.20 in) on theperiphery of end walls 27. Support rails 28 are press fitted into thereceiving cavities 43 on end walls 27 a, 27 b. In another embodiment,support assembly 23 is completely encased, such that the variouscomponents positioned on support rails 28 are not visible. Overall, thelength of support assembly 23 is approximately 110 mm to 150 mm with apreferred length of about 139.70 mm (5.50 in) with a height and widthranging from about 30 mm to about 60 mm and a preferred height and widthof approximately 50.04 mm (1.97 in). In a preferred embodiment, thebottom side of second end wall 27 b is contoured to compliment thenatural curve of the user's forearm.

End walls 27 a, 27 b both have central bores 36 a, 36 b, respectively.Central bore 36 a provides an attachment site for securing elongatetubular member 1 to user interface 4. Elongate tubular member may besecured to interface 4 by any convenient means including but not limitedto a press fit within bore 36 a or threaded into bore 36 a.Additionally, central bore 36 a provides a passage for cabling members 6a, 6 b, 6 c, 6 d, and 6 e, to enter elongate tubular member 1. Alsodepicted in FIGS. 3, 13, and 14 is guide member 37 having guide cavities38 a, 38 b, 38 c, 38 d, 38 e, and 38 f Guide member 37 may be positionedat any convenient location including but not limited to within centralbore 36 a or within the interior of tubular member 1. Alternatively,guide member 37 may be secured to first end wall 27 a, axially with bore36 a, and may act as an attachment point for tubular member 1. Guidemember 37 provides each cabling member 6 an isolating cavity 38.Isolating cavity 38 acts as a guide isolating cable members 6 from oneanother thereby precluding entanglement of cabling members 6.Preferably, guide member 37 is made from stainless steel and has anapproximate diameter ranging from about 5 mm to about 15 mm with apreferred diameter of about 12 mm (0.47 in) and is located inside theproximal end 3 of elongate tubular member 1. In a preferred embodiment,is press fitted until flush within proximal end 3 of elongate tubularmember 1. Elongate tubular member 1 is made from stainless steel andpreferably has an outside diameter of about 5 mm to about 12 mm with apreferred outside diameter of 12 mm (0.47 in), an inner diameter ofabout 4 mm to about 11 mm with a preferred inner diameter of 11 mm (0.43in) and length of about 304.8 mm to about 457.2 mm with a typical lengthof about 304.8 mm (12 in) depending upon the procedure to be performed.

In a preferred embodiment, the ball and socket assembly 11 is slideablypositioned on support rails 28 with socket 22 carried on support rails28 passing through passages 40. The slideable configuration permitspositioning and securing of ball and socket assembly 11 along supportrails 28 based on user preference. For example, positioning ball andsocket assembly 11 near the center of support assembly 23 provides moreflexibility to the user in adjusting the cable tension. For example,turning locking rod 25 clockwise causes the ball and socket assembly 11to move closer to second end wall 27 b, thereby increasing the tensionin cabling member 6. Handle assembly 7 is directly coupled to the balland socket assembly 11 for direct transference of movement of handleassembly 7 to the articulating tool assembly 5 via cabling member 6.

As shown in FIG. 3, central bore 36 b allows for locking rod 25 toextend through second end wall 27 b to secure the ball and socketassembly 11 at the desired location on the support assembly 23. In oneembodiment, locking rod 25 is a ¼ in—20NC bolt with a length ofapproximately 38.1 mm (1.5 in) to 50.8 mm (2.0 in). In the preferredembodiment, a threaded recess 26 carried by each half 22 of socketassembly 11 forms a threaded bore for receiving threaded locking rod 25.The threaded engagement between locking rod 25 and socket assembly 11provides the ability to adjust the tension of cabling members 6 bymoving socket assembly 11 towards or away from second end wall 27 b.Additionally, locking rod 25 carries a a wing nut 47. Following settingof the desire tension, tightening of wing nut 47 against the exterior ofsecond end wall 27 b fixes the relationship of locking rod 25 and socketassembly 11 thereby maintaining the desired tension on cabling members6.

As depicted in FIGS. 1-3, ball and socket assembly 11 is positioned onsupport assembly 23. Ball and socket assembly 11 includes ball 20,depicted in FIGS. 3 and 15. Generally spherical in shape, ball 20 hastop, bottom, left, and right protruding arms 21 a, 21 b, 21 c, and 21 d,respectively. In a preferred embodiment, protruding arms 21 arecylindrical in shape; however, arms 21 can be any suitable shape forcoupling cabling member 6 to ball 20. In one embodiment ball 20 is has adiameter of about 15 mm to about 25 mm. Typically, the diameter will beabout 19 mm (0.75 in). The preferred ball 20 is made of stainless steel.Each protruding arm provides an attachment point for one cabling member6 (6 a, 6 b, 6 c, and 6 d).

Cabling members 6 should be prepared from material that is strong andsurgically safe. Suitable material includes but is not limited to 304stainless steel nylon coated cable. Any similar component suitable foroperatively coupling user interface 4 with articulating tool assembly 5will perform satisfactorily in the current invention, such similarcomponent can be used in, for example, non-surgical procedures such astraining or demonstrative purposes. Securing member 24 can be anysuitable device known in the art, for example, bolts, pins, buttons,press-fitted pins, and screws or any similar component suitable forsecuring cabling member 6 to protruding arms 21 a, 21 c, and 21 d willperform satisfactorily in the current invention. In a preferredembodiment, protruding arms 21 a, 21 b, 21 c, and 21 d are internallythreaded to receive securing member 24, for example, a screw. In thepreferred embodiment, both securing member 24 and locking rod 25 providethe ability to adjust the tension of cabling member 6. In thisembodiment, manipulation of securing member 24 can either increase ordecrease tension on cabling member 6. Alternatively, cabling member 6 isattached directly to protruding arms 21 a, 21 b, 21 c, and 21 d by anyconvenient arrangement, such as but not limited to, tying or soldering.In the preferred embodiment, support assembly 23, including locking rod25 will be enclosed in an aesthetically pleasing shroud or cover (notshown).

Referring to FIGS. 1, 2, 4, 5B, 5C, 15 and 16, ball 20 is disposedwithin a spherical cavity formed by socket members 22 a, 22 b of socket22. Assembled socket 22 has openings 44 to receive protruding arms 21 a,21 b, 21 c, and 21 d to permit unobstructed movement of ball 20 withinsocket 22. This configuration provides the optimal range of movement forball 20. As discussed above, this range of movement translates directlyto articulating tool assembly 5.

In one embodiment, top and bottom openings 44 a, 44 b (only onedepicted) of socket 22 through which top and bottom protruding arms 21a, 21 b project are generally elliptical in shape thereby restrictingthe range of motion of the top and bottom protruding arms. However, theopenings 44 c, 44 d through which left and right protruding arms 21 c,21 d project are generally rectangular in shape thereby permitting afull range of left and right movement with respect to the location ofthe top and bottom protruding arms 21 a, 21 b.

As shown in FIGS. 2 and 16, the preferred embodiment utilizes a socket22 with a periphery having a generally “X” shaped configuration withrecessed portions defining an arcuate concave surface. The arcuateconcave surface prevents cabling member 6 from becoming lodged or stuckat the apex of the recessed portions. The dimensions and material ofsocket 22 can vary per application; in one preferred embodiment socket22 is made of stainless steel having outermost dimensions of 40 mm (1.57in) long, 40 mm (1.57 in) wide and 40 mm (1.57 in) deep. However, socket22 may have a length ranging from about 25 mm to about 50 mm, a widthranging from about 25 mm to about 50 mm and a depth ranging about 25 mmto about 50 mm.

Similarly and for the same reasons of socket 22, slide block 41preferably has a generally “X” shaped periphery. Slide block 41 ispositioned on the support rails 28 between first end wall 27 a and balland socket assembly 11. In a preferred embodiment, slide block 41 isslideably mounted on support rails 28. Slide block 41 provides supportfor cabling 6 and channels cabling 6 to elongate tubular member 1. Inone embodiment, slide block 41 is made of stainless steel and is 40 mm(1.57 in) wide, 40 mm (1.57 in) long and has a thickness of 6.5 mm (0.25in). However, slide block 41 may have a width ranging from about 25 mmto about 50 mm, a length ranging from about 25 mm to about 50 mm and athickness ranging from about 8 mm to about 25.4 mm.

In a preferred embodiment, handle assembly 7 includes grip member 8 andlever member 9 pivotally coupled to grip member 8 at pivot point 10 a.Preferably, grip member 8 and lever member 9 will be ergonomicallydesigned to comfortably fit within the surgeon's hand. In one embodimentgrip member 8 is 162.6 mm (6.4 in) long with a diameter of 19 mm (0.75in) and is made of metal, metal alloys, plastics and composites. In thisembodiment, lever member 9 is 94 mm (3.7 in) long and made of metal,metal alloys, plastics and composites.

Grip member 8 is directly coupled to ball 20 at bottom protruding arm 21b, thereby directly translating movement of handle assembly 7 to balland socket assembly 11. Lever member 9 actuates the opening and closingof tip assembly 12. Actuating lever member 9 counterclockwise andclockwise about pivot point 10 a causes tip assembly 12 to move betweenfully closed and fully open, respectively, and all positionstherebetween.

In a preferred embodiment, articulating tool assembly 5 includesinterchangeable tip assembly 12. Depending on the intended use ofinstrument 100, tip assembly 12 may be selected from any of thefollowing non-limiting examples: graspers, dissectors, scissor and bladetip assemblies. To provide cauterization capabilities, one of thecabling members 6 (typically 6 e) or an additional wire (not shown)provides an electrical current to the distal end of tip assembly 12. Forcauterization purposes, the material forming the distal end of tipassembly 12 responds to the electrical current by producing heatsufficient to cauterize tissue. Except with regard to the distal end oftip assembly 12, the remaining portion of instrument 100, which comesinto contact with tissue, will be insulated to protect the surroundingtissue from injury.

FIGS. 5A, 6, 7, and 8 depict a grasper embodiment of tip assembly 12. Asshown, tip assembly 12 includes a moving member 29 pivotally connectedto base member 30 at pivot point 10 b with pivot fastener 32 b. Pivotfasteners 32 a, 32 b, 32 c, and 32 d can be any fastener, suitable foroperatively connecting the various components which are pivotallyconnected. Fasteners such as bolts, pins, buttons, press-fitted pins,and screws or any similar component will perform satisfactorily in thecurrent invention.

To open tip assembly 12, the user will move actuating lever member 9counterclockwise with respect to pivot point 10 a. Conversely, to closetip assembly 12, the user will move actuating lever member 9 clockwise.In a preferred embodiment, lever member 9 and tip assembly 12 areoperatively connected via cabling member 6 e. As shown in FIGS. 1-5C and8, a single cable 6 e positioned within a circumferential groove 34 oflever member 9 (FIG. 3), through holes 35 (only one depicted) of gripmember 8, and extends through elongated tubular member 1 and loopsaround moving member 29 within circumferential groove 33 beforeextending back through elongated tubular member 1 to lever member 9.Thus, actuating lever member 9 causes moving member 29 of tip assembly12 to move in relation to base member 30 about pivot point 10 b. In thisembodiment, cabling member 6 e passes through the central bore 42 ofslide block 41 and isolating cavities 38 e and 38 f as shown in FIGS.5A-6 and 8-14. Cabling member 6 e may be either a single continuous loopor a single strand with both ends of the strand secured to a convenientpoint 46 on lever member 9.

In another embodiment, cabling member 6 e is shielded between handleassembly 7 and slide block 41 to prevent any entanglement of 6 e withthe other cabling members. With reference to FIGS. 8-14 and from thevantage point of looking down the longitudinal axis of elongate tubularmember 1 from user interface 4, the cross sectional views of the variouscomponent pieces, e.g. base member 30, dual hinge member 13, elongateguide member 17, and guide member 37, align in a manner to confinecabling members 6 within each respective isolating cavity 38 therebyprecluding entanglement with adjacent cabling members 6. It should beappreciated that the routing of cabling members 6 within isolatingcavities 38, as depicted in the figures, is just one embodiment of thecabling configuration.

Turning now to FIGS. 5A and 6, articulating tool assembly 5 alsoincludes elongate guide member 17 and dual hinge member 13. Dual hingemember 13 has a first side 14 and a second side 15. See also FIGS.10-12. Tip assembly 12 and elongate guide member 17 are pivotallycoupled to dual hinge member 13 at pivot points 10 c and 10 d,respectively. The coupling provides a pivotal tongue and groove joint.As shown in FIGS. 6-8, tip assembly 12, specifically base member 30 hasa “tongue.” Base tongue 31 is a convex surface extending from the backof base member 30. In one embodiment base tongue 31 is in the form of athin, outwardly projecting semi-circular member. A cross sectional viewof the back of base member 30 is shown in FIG. 9. Base tongue 31 alsohas a through hole as pivot point 10 c for pivotal coupling to dualhinge member 13. First side 14 of dual hinge member 13 carries thecorresponding groove which received base tongue 31. As shown in FIGS. 6and 10, the first side 14 of dual hinge member 13 is two convex surfacesdefining the groove for receiving base tongue 31. Likewise, first side14 also has through holes for pivotal coupling to base member 30 withpivot fastener 32 c. As depicted in FIG. 6, the operative coupling ofbase member 30 with dual hinge member 13 permits vertical movement, i.e.up and down movement, of tip assembly 12 with respect to thelongitudinal axis 39 of elongate tubular member 1 as depicted in FIG. 3.For example, cabling members 6 a and 6 b, shown in FIGS. 1, 2 and 6operatively connect to the top and bottom protruding arms 21 a, 21 b,respectively, of ball 20. When a user moves handle assembly 7, forexample, forwards or backwards along longitudinal axis 39 of elongatetubular member 1, the tip assembly 12 vertically pivots about point 10c.

Pivot point 10 d controls lateral movement, i.e. left and rightmovement, with respect to the longitudinal axis 39 of elongate tubularmember 1. As depicted in FIG. 6, elongate guide member 17 is pivotallyconnected to the second side 15 of dual hinge member 13. Similar to thebase member 30, elongate guide member 17 has elongate guide tongue 16,an outwardly projecting convex surface having a through hole for pivotpoint 10 d. In the depicted embodiment, elongate guide tongue 16 is inthe form of a thin outwardly projecting semi-circular surface. Likewise,the second side 15 of dual hinge member 13 is pivotally coupled toelongate guide tongue 16 to form a pivotal tongue and groove jointproviding lateral movement.

For example, cabling member 6 c and 6 d, shown in FIGS. 1, 2, and 6,operatively connect to the left and right protruding arms 21 c, 21 d,respectively, of ball 20 to dual hinge member 13. As discussed above,the configuration of openings 44 a, 44 b, 44 c, and 44 d define thelimits of movement for protruding arms 21. Thus, operation of handleassembly 7, for example twisting or rotating clockwise orcounterclockwise with respect to support assembly 23 manipulates ball 20within socket 22. For example, such manipulation translates down cabling6 c and 6 d causing dual hinge member 13 to laterally pivot about point10 d. As already discussed and shown in FIGS. 3, 4, and 16, socket 22has openings 44 to allow for protruding arms 21 to move unobstructedwithin a defined area. Lateral movement occurs as a result of theposition of left and right protruding arms 21 c and 21 d, respectively.

It should be appreciated that the orientation of base tongue 31 andelongate tongue 16 are not limited to configuration described above.Other arrangements may be dictated by the nature of tip assembly 12 andthe intended use thereof.

As shown in FIGS. 1-3, elongate guide member 17 is optionally coupled byjoiner 18 to the distal end 2 of elongate tubular member 1. Joiner 18has a tubular configuration with a diameter less than that of elongatetubular member 1 and elongate guide member 17. Additionally, joiner 18has a centrally located flange 45. When assembled, flange 45 is flushwith elongate tubular member 1 and elongate guide member 17 as depictedin FIGS. 1 and 2. Preferably joiner 18 is secured within elongatetubular member 1 and elongate guide member 17 removably slides overjoiner 18. In alternate embodiments, either elongate tubular member 1and elongate guide member 17 are joined directly to one another by anyconvential arrangement. For example, elongate tubular member 1 may betapered at distal end 2 such that elongate guide member 17 is slidablypositioned over the tapered portion. Additionally, any similar componentsuitable for operatively coupling elongate tubular member 1 withelongate guide member 17 will perform satisfactorily in the currentinvention.

Instrument 100 is not limited to the dimensions and types of materialused and configurations described above. Such characteristics ofinstrument 100 will vary depending on the application or use, forexample, the type of surgical procedure, e.g. human or veterinarysurgical procedures; size of patient or subject; use for training suchas, but not limited to use on mannequins or cadavers; use fordemonstrative purposes in various environments such as commercialsettings like trade shows, medical offices, academic settings, orprivate settings. It should be appreciated that any similar componentsuitable for satisfactorily performing the function of the correspondingcomponent can be used in the current invention.

Thus, the present invention is well adapted to carry out the objects andattain the ends and advantages mentioned above as well as those inherenttherein. While certain embodiments of the invention have been describedfor the purpose of this disclosure, numerous changes in the constructionand arrangement of parts and the performance of steps can be made bythose skilled in the art, which changes are encompassed within the scopeand spirit of this invention defined by the appended claims.

What is claimed is:
 1. An instrument comprising: an elongate tubularmember having a distal end and a proximal end; an user interface coupledto said proximal end; an articulating tool assembly coupled to saiddistal end; at least one cabling member extending through the elongatetubular member, said cabling member operatively connecting said userinterface and said articulating tool assembly such that movement made atsaid articulating tool assembly directly corresponds to and mimicsmovement of said user interface.